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This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC 90-1170, initial dose | Experimental |
| |
| NNC 90-1170 | Experimental |
| |
| Insulin | Active Comparator |
| |
| NNC 90-1170, final dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of the areas under the plasma NN 90-1170 curves |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum concentration (Cmax) | ||
| The time to maximum concentration (tmax) | ||
| Mean residence time (MRT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tranent | EH33 2NE | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| placebo | Drug | Single dose by inhalation. Progression to open-label trial part will be based on safety data |
|
| liraglutide | Drug | Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order |
|
| liraglutide | Drug | Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order |
|
| insulin human | Drug | Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order |
|
| insulin human | Drug | Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order |
|
| liraglutide | Drug | 24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation |
|
|
| Area under the curve |
| Terminal rate constant |
| Adverse events |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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